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news.AtriCure has reported that the first patient was successfully treated in company's Ablate clinical trial to evaluate the safety and effectiveness of Isolator Synergy bipolar ablation system for reestablishing normal heart rhythm in patients with permanent atrial fibrillation, or AF.
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This prospective, non-randomized clinical trial is expected to enroll approximately 70 patients at 10 medical centers in the US. The primary efficacy endpoints for the trial are patients being free from AF and off anti-arrhythmic drugs at six months.
Upon the completion of a successful trial, the results will be submitted to the FDA as part of a pre-market approval, or PMA, in support of an AF indication for the Isolator Synergy bipolar ablation system when used to treat patients undergoing concomitant open-heart surgery.